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New system alerts physicians to bleeding complications

Product innovator Cambridge Consultants has been chosen by Texas biomedical start-up Saranas to help develop an early-warning system for bleeding complications during interventional catheter-based procedures.

The device is aimed at medical procedures requiring access to a blood vessel – such as transcatheter aortic valve replacements (TAVRs), where the femoral artery is used to gain access to the heart.

Although they avoid the need for open-heart surgery, vascular access procedures are not without risk. A sheath needs to be inserted into the artery as a conduit for the other equipment involved in the operation.

Bleeding complications can arise during the initial access if the needle accidentally pierces the blood vessel. As there are no outward symptoms of the puncture, the patient can bleed undetected until a significant amount of blood is lost.

The new Saranas Observer System (SOS) uses electrical resistance to detect blood loss in real time and alert the physician. The system consists of a standard introducer sheath fitted with electrodes that measure the difference in electrical resistance across the blood vessel. If the artery is punctured, blood begins to accumulate outside the blood vessel – causing a change in the electrical resistance. The SOS is able to detect this change and alert the physician.

“Detecting a small bleed in an area where there is already a lot of blood is particularly challenging,” said John Genova, project director at Cambridge Consultants.

“Our extensive track record of medical product development convinced Saranas that we were the right choice to take on the challenge and make the concept a commercial reality.

Until now, there has been no way to specifically monitor, in real time, access site bleeding complications. With the Saranas system, miniaturised electronics in the cardiac sheath will give the doctor an instant warning as soon as bleeding is detected.

“Our technology is a cost-effective solution that benefits the patient, the physician and the hospital,” said Michael Magnani, CEO of Houston-based Saranas. “In addition to being economically viable, the system is easy to use.

“We chose Cambridge Consultants as a development partner as it has all the skills we need under one roof – from mechanical engineering and wireless communications to human factors and industrial design.

“It even has a simulated operating room where physicians can test the technology in a realistic environment.”